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Buprenorphine for Pain After Ankle Fracture Surgery

This study is looking at whether buprenorphine transdermal system (a patch) can safely and effectively manage pain after ankle fracture surgery, and potentially reduce the risk of opioid addiction. Many people use addictive opioids like oxycodone after surgery, and about 1 in 5 patients who didn't use opioids before surgery can become addicted. Buprenorphine is an opioid that may be less addictive and cause less of a "high" while still providing good pain relief. You might be able to join if you are 18 or older, are having surgery for a single ankle fracture, and speak English. The study will measure how many morphine milligram equivalents of full-agonist opioids (like oxycodone) you use in the first 7 days after surgery and at your first clinic visit (around 3 weeks after surgery). The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 100 participants. Participants will receive either the buprenorphine transdermal system or a placebo patch before surgery.
What's involved
Participants will have a patch applied before surgery. They will also receive standard care if assigned to the placebo group.
Compensation
Not stated in the trial record.
Follow-up
The study will track opioid use for 7 days after surgery and at the first post-operative clinic visit, which is approximately 3 weeks after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06949826

Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery

Recruiting
PHASE4Ages 18+InterventionalTreatment
Jenna-Leigh Wilson
~100 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Buprenorphine Transdermal SystemPlacebo Patch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Morphine Milligram Equivalents of Full-agonist Opioid Consumed
Measured over Post-operative days 0-7. First post-operative clinic visit (approximately 3 weeks after surgery).

Conditions

Pain, Postoperative
Ankle Fracture Surgery
Opioid Use Disorder
Opioid Dependence
Opioid Analgesia

Explore related trials

Ankle Fracture

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Jenna Wilson, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Noah J Harrison, MD, MMSc
[email protected]
314-459-1140
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient is 18 years of age or older
Patient is undergoing single stage ORIF of an ankle fracture
Patient is English-speaking

Exclusion

Patient is under 18 years of age
Patient's ankle fracture is treated with external fixation
Patient has a concomitant osseous or visceral injury
Patient has a history of opioid use disorder or a current diagnosis of opioid use disorder
Patient has a history of alcohol use disorder or a current diagnosis of alcohol use disorder
Patient was taking opioid medication or narcotic drugs prior to their injury
Patient has a current active malignancy
Patient is taking a medication that carries a prohibitively high risk of drug-drug interaction with buprenorphine, hydrocodone, or oxycodone in the view of their treating physician or nurse anesthetist
Patient has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone
Patient is not English-speaking
Patient is pregnant
Patient is unable to complete pain diary or communicate pain scores
Patient is incarcerated
Patient has a Gustilo-Anderson Type III open fracture

What this trial measures

  • Morphine Milligram Equivalents of Full-agonist Opioid ConsumedPost-operative days 0-7. First post-operative clinic visit (approximately 3 weeks after surgery).

    After surgery, patients will record the total amount of opioid medication they consumed during the first post-operative week in their pain diary. In admitted patients, the electronic medical record will be reviewed to determine the morphine milligram equivalents of opioid consumed while admitted. Patients will also bring all their bottles and opioid prescriptions to their first post-operative clinic visit, at which point their total opioid consumption between surgery and their first post-operative clinic visit will be recorded by the researchers.